Cleared Traditional

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

K181208 · Vygon USA · General Hospital

Nov 2018

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K181208 is an FDA 510(k) clearance for the Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Vygon USA (Lansdale, US). The FDA issued a Cleared decision on November 2, 2018, 179 days after receiving the submission on May 7, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K181208 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2018
Decision Date	November 02, 2018
Days to Decision	179 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.